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HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-02-04

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 4, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), and Mike Yang (ScienTek Software)

  • The style sheet will not display the “title” attribute in Test (page 60 of IG) for a level 1 test, but will for a level 2 test. Catherine is looking into changing that in the style sheet.
  • We will final the IG for submission to HL7 and FDA web site.
  • Changes to schematron (add to validation document): 1) Check for associated files if Cycled study is picked, 2) Check for code system names, 3) Check for Stability preferred terms (including the case), and 4) Why are eCTD file names failing?

Agenda for February 11, 2013 Teleconference: